510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,569

176,366 records, page 3291 of 3528

510(k) clearances, page 3291 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K811103	Ge 900	General Electric Co.	EHD	Class II	1981-06-09
K810699	Pantops M-2 Electrophysiology System	Visidyne Corp.	HLX	Class II	1981-06-09
K810133	Ultraprobe	Ars Magna	IYN	Class II	1981-06-09
K810066	Cobe Ppd .8	Cobe Laboratories, Inc.	FJG	Class II	1981-06-09
K803218	Cell Dyn 800 Hematology Analyzer	Abbott Diagnostics	GKL	Class II	1981-06-09
K803183	Offenback Reversible Barium Pump	The Offenback Co.	FRN	Class II	1981-06-09
K811452	Brown-Roberts-Wells Stereotaxic Sytem	Trent Wells, Inc.	HAW	Class II	1981-06-02
K811413	Dabc Nonconductive Pediat. Anesth. Cir	Airco/Ohio Medical Products	CAI	Class I	1981-06-02
K811409	Argyle CPAP Nasal Cannula	Sherwood Medical Co.	BZD	Class II	1981-06-02
K811378	Percutaneous Draining Catheter	Medi-Tech, Inc.	GBW	Class I	1981-06-02
K811320	Cal-3 Calibrated Radioactivity Assayer	Dosimeter Corp.	KPT	Class II	1981-06-02
K811311	Skytron Elite Surgical Tables	Skytron, LLC	GBC	Class II	1981-06-02
K811292	Parallel Plate Dialyzer Holder	Extracorporeal Medical Specialities, Inc.	FKI	Class II	1981-06-02
K811291	Tegaderm Transparent Dressing	3M Company	KGX	Class I	1981-06-02
K811280	Flex-Template	Mick Radio-Nuclear Instruments, Inc.	KDC	Class I	1981-06-02
K811278	Extended Tumor Caliper	Mick Radio-Nuclear Instruments, Inc.	FTY	Class I	1981-06-02
K811265	Respiratory Sensor (Model 409 W/nasoph.)	ZOLL Medical Corporation	BZQ	Class II	1981-06-02
K811238	Model 560 Series Volumetric Infusion	Y	FRN	Class II	1981-06-02
K811224	Ministim	Medical Design & Manufacturing Corp.	GZJ	Class II	1981-06-02
K811192	Vac-Rite Sunction Collection	BD Becton Dickinson Vacutainer Systems Preanalytic	KDQ	Class II	1981-06-02
K811185	N-D0-Sure	Ackrad Laboratories	CBH	Class I	1981-06-02
K811166	Surgical Dressing Set	Washington-Greene County Branch Pennsylvania Assoc			1981-06-02
K811160	Sur-Fit Irrigation Sleeve	E. R. Squibb & Sons, Inc.	EXD	Class II	1981-06-02
K811118	Krypton Masks & Tubing	Medi-Physics Inc. dba Nycomed Amersham Imaging	IYT	Class II	1981-06-02
K811029	Sunlamp	Williams & Connolly	FTC	Class II	1981-06-02
K811014	Respiratory Sensor	ZOLL Medical Corporation	BZQ	Class II	1981-06-02
K811006	Solution Administration Set	Suru Chemicals & Pharmaceuticals, Ltd.	FPA	Class II	1981-06-02
K810979	Arrow Needle-Catheter Jejunostomy Kit	Arrow Intl., Inc.	KNT	Class II	1981-06-02
K810947	Air Entrainment Trach T	Airlife, Inc.	BYF	Class I	1981-06-02
K810946	Adult & Pediatric Tracheostomy Masks	Airlife, Inc.	BYF	Class I	1981-06-02
K810726	Formulation Change in United Skin Barr	Howmedica Corp.	EXB	Class I	1981-06-02
K803264	Sunlamp	Am Labs, Inc.	FTC	Class II	1981-06-02
K811012	TENS-O-Matic	O-Matic, Inc.	GZJ	Class II	1981-06-01
K810469	Steriledge Self Seal Pouch	Beacon Converters, Inc.	KCT	Class II	1981-06-01
K811398	Early Pregnancy Detection	Immuchem Corp.	JHI	Class II	1981-05-29
K811392	Ames Sera-Pak Glucose Reagent	Miles Laboratories, Inc.	CGA	Class II	1981-05-29
K811371	Natal-Tec Estriol	Armkel, LLC	CGI	Class I	1981-05-29
K811370	Natal-Tec Hpl	Armkel, LLC	JMF	Class II	1981-05-29
K811369	Natal-Tec Progesterone	Armkel, LLC	JLS	Class I	1981-05-29
K811367	Kallestad Antisera to Phenobarbital	Kallestad Laboratories, Inc.	DLZ	Class II	1981-05-29
K811362	Tcbs Agar	Neogen Culture Media	JSI	Class I	1981-05-29
K811361	Pancreatic Hydrolysate of Heart Muscle	Neogen Culture Media	JSK	Class I	1981-05-29
K811360	Yeast Extract	Neogen Culture Media	JSK	Class I	1981-05-29
K811359	Agar, Bacteriological	Neogen Culture Media	JSG	Class I	1981-05-29
K811358	Dehydrated Bile	Neogen Culture Media	JAK	Class II	1981-05-29
K811357	Hemoglobin Powder	Neogen Culture Media	JSK	Class I	1981-05-29
K811356	Tryptone Azolecithin Tween	Neogen Culture Media	JSJ	Class I	1981-05-29
K811355	Lysine Iron Agar	Neogen Culture Media	JSI	Class I	1981-05-29
K811354	Gn Broth (Hajna)	Neogen Culture Media	JSJ	Class I	1981-05-29
K811353	Brain Heart Infusion W/o Dextrose	Neogen Culture Media	JSG	Class I	1981-05-29